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Commissioning Qualification Validation Engineer

Employer
Discover International
Location
Kansas City, Missouri
Salary
Based on experience within the industry
Start date
23 Nov 2022
Closing date
23 Dec 2022

View more

Discipline
Manufacturing, Validation, Quality, Quality Validation Engineer
Hours
Full Time
Contract Type
Contract
Experience Level
Entry level
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Job Details

Responsibilities:

  • Support IQ/OQ and/or PQ activities, re-qualification, enrollment or qualification/commissioning for utilities and equipment used in GMP work environment Responsible for creating, updating, and maintaining associated documentations and reports relevant to project. Lead a project and oversight of validation deliverables among multiple groups in the organization Ensure clear communication and alignment between cross-functional groups. Author, execute and/or review validation documents such as change controls, validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA, and validation exceptions/deviations Schedule and execute validations per standard operating procedures (SOP) and regulatory guidelines Participate in validation related investigations Champion and lead continuous improvement efforts on every aspect of validation Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions Foster cross-departmental relationships (QC, materials management, manufacturing, QA and site leadership) by representing validation at team meetings Employ good document practices (GDP) when recording data, maintaining archives, and drafting or reviewing documents Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures Use good engineering practice on assigned duties Champion assigned CRs and/or CAPAs in coordinating with multiple stakeholders Apply strategies and prioritize tasks with management Revise and maintain assigned validation procedures

Company

At Discover International there is a genuine sense of pride in what we do. We are incredibly motivated to offer an outstanding service to our customers, and are proud of our commitment to be the best in our field. We are inspired by the brilliant clients and candidates in life science that we partner with and continue to grow lasting relationships with.

We are proud of our global colleagues, of our team ethos, of our numerous high achievers. We are proud of the personal development and career opportunities we offer and we are extremely excited by the journey we are on together as a team.

Find Us
Website
Location
Brickell City Tower
80 SW 8th St
Miami
Fl 31330
US
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